The Hamilton Group is a leader in the development and production of liquid handling and process analytics in the core areas of BioPharma and ChemPharma. The high-tech company with 2,500 employees worldwide has been setting sales records for several years and, with its plants in Bonaduz and Domat/Ems, has become one of the most important employers in Eastern Switzerland. Thanks to a high level of automation and almost flawless production, the Swiss plants are able to maintain a competitive advantage on the international market. A new building has now been put into operation in Domat/Ems, which has been tailored precisely to the needs of safe and efficient production. The modern glass building, whose roof and façade are clad in photovoltaics, boasts highly automated storage and production.
The centerpiece of the new building is a 560 square meter Cleanroom of ISO class 8, which was built for the production of pipette tips. Here, 2.5 billion individual parts are produced, tested and prepared for safe shipment every year. The applications of the tips include molecular biology research and laboratory diagnostics, such as DNA analysis. The smallest quantities of liquid must be pipetted precisely. The pipettes must not contain any traces of DNA, RNase or endotoxins/pyrogens to ensure the safety of the diagnoses. In order to guarantee this to customers, Hamilton relies on controlled production under clean room conditions.
Innovative technology also defines the CleanMediCell cleanroom system from SCHILLING ENGINEERING, which was designed precisely for the requirements that arise when handling the high number of sensitive plastic components.
In addition to the actual Cleanroom, which guarantees ISO class 8 air quality, the cleanroom specialist also supplied the laminar flow enclosures for the injection molding machines to ensure contamination-free production. The pipette tips are manufactured in a controlled injection molding process. Each machine is equipped with a laminar flow enclosure, which protects the open areas of production from contamination with a controlled supply of ISO class 5 clean air. The finished parts are now grouped fully automatically into trays of 96 pieces each via cleanroom conveyor belts and a connected robot handling system and fed into the Cleanroom. Contamination is ruled out in this way.
The principle of cleanroom technology is based on high-performance filters that filter particles from the ambient air. The low-particle air is flushed into the Cleanroom and displaces the airborne particles that are still in the Cleanroom in permanent air changes. The Cleanroom has a connected air conditioning system and is operated at a constant temperature and humidity. The cooled and filtered air is fed back into the recirculated air circuit in an energy-efficient and filter-friendly manner. The low-cost deep well water is used for cooling.
The cleanroom system is equipped with 900 lux LED lighting. The GMP Cleanroom strip lights are integrated flush into the aluminum profiles and create a very bright yet pleasant light. In addition to the artificial light, the Cleanroom was equipped with large windows that provide natural lighting and also blend in very well with the modern surroundings of the redesigned building.
The required media are integrated flush with the surface and run inside the wall, which makes them very easy to clean.
The wall and ceiling modules of the cleanroom are connected with a silicone-free sealing clip system, which ensures that the room is extremely airtight. Thanks to the modular design and the patented connection, SCHILLING ENGINEERING cleanrooms can be easily converted or extended.
A special feature of the cleanroom system is the integrated GMP monitoring. The particle concentration within the cleanroom is monitored, as are the parameters of pressure, humidity and temperature. All values are constantly recorded and documented. The controlled process, which meets the high GMP requirements, can thus be verified over the entire production period. The measurements and settings are combined in the control system CR-Control®which is controlled via an easy-to-operate touchscreen. Maintenance and error messages are displayed here, and all parameters, including the air conditioning technology, can be easily selected and controlled.
The safe entry and exit of employees and materials is another important aspect of any cleanroom concept. This takes place via separate airlock systems. Employees enter Cleanroom via a specially furnished personnel airlock, where they change into cleanroom clothing that emits few particles. At Cleanroom, the pipette tips are checked, partially sterilized and packaged. The double-packed end product is safely transported out via the material airlock and can now find its way to the end customer without any risk.
The cleanroom system from SCHILLING ENGINEERING was put into operation just in time for the opening of the new building in Domat/Ems, which was also attended by the American Managing Director Steve Hamilton from Nevada.
This article was published: Plastverarbeiter 5/2019
